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Outcome of Glargine Insulin in Renal Impairment Patients With Diabetic Ketoacidosis

Primary Purpose

Chronic Kidney Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Glargine
normal saline
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female patients.
  • Type I and type II diabetes mellitus.
  • Patients on insulin and/or oral hypoglycemic therapy.
  • Duration of diabetes more than 5 years.
  • Medical and surgical patients.

Exclusion Criteria:

  • Severe persistent hypotension (SBP <80 inspite of receiving 1000ml of normal saline).
  • Acute myocardial infarction.
  • Progressive renal failure or end stage renal disease defined as eGFR < 15ml/min.
  • Liver cell failure.
  • Pregnancy.
  • Need for emergency surgery

Sites / Locations

  • Ain Shams UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

low dose insulin infusion +Subcutaneous saline

low dose insulin infusion +subcutaneous Glargine insulin

Arm Description

low dose insulin infusion +Subcutaneous saline

low dose insulin infusion +subcutaneous Glargine insulin

Outcomes

Primary Outcome Measures

Mean time to reversal of diabetic ketoacidosis
Resolution of DKA is defined as blood sugar <200mg/dl plus any two of serum bicarbonate ≥15,pH>7.3, and anion gap less than or equal to 12
Total crystalline insulin consumption
Total number of units of insulin infusion consumed for diabetic ketocidosis to resolve

Secondary Outcome Measures

Full Information

First Posted
January 9, 2022
Last Updated
June 6, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05219942
Brief Title
Outcome of Glargine Insulin in Renal Impairment Patients With Diabetic Ketoacidosis
Official Title
Outcome of Using Long Acting Glargine Insulin With Low Dose Regular Insulin Infusion in Diabetic Ketoacidosis Patients :A Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study aims to compare between the use of continuous low dose insulin infusion versus co-administration of low dose continuous insulin infusion and early subcutaneous insulin glargine in diabetic ketoacidosis patients with chronic renal impairment. aim to investigate the effect of using the long acting insulin analogue glargine on the resolution time of diabetic ketoacidosis in renal impairment patients who have altered insulin pharmacokinetics and pharmacodynamics and the rate of adverse effects of this approach
Detailed Description
Diabetic ketoacidosis (DKA) is one of the most common and grave acute complications of diabetes and is a significant cause of morbidity and mortality. The current available guidelines state that the most effective means of insulin delivery during DKA is a continuous low dose infusion of regular insulin. The patients must be admitted to the ICU for frequent and close monitoring .In addition to insulin infusion, correction of dehydration, and electrolyte and acid base disorders is achieved together with identification and treatment of co-morbid precipitating factors . "The Joint British Diabetes Societies guideline for the management of diabetic ketoacidosis" recommends continuation of a long-acting insulin analogue such as insulin glargine during the initial management of DKA because it provides background insulin when the intravenous insulin is discontinue. Administering basal insulin concomitantly with regular insulin infusion was found to be well tolerated, associated with faster resolution of acidosis without any adverse effects; patients required a shorter duration of intravenous insulin infusion and had a lower total dose of intravenous insulin and significantly decreased hyperglycemia after discontinuation of the intravenous insulin .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Patients of both groups know that they will receive crystalline insulin infusion.However they are not told whether they receive glargine insulin or not.
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
low dose insulin infusion +Subcutaneous saline
Arm Type
Placebo Comparator
Arm Description
low dose insulin infusion +Subcutaneous saline
Arm Title
low dose insulin infusion +subcutaneous Glargine insulin
Arm Type
Active Comparator
Arm Description
low dose insulin infusion +subcutaneous Glargine insulin
Intervention Type
Drug
Intervention Name(s)
Glargine
Other Intervention Name(s)
insulin
Intervention Description
regular low dose insulin infusion 0.1 IU/Kg/hour and subcutaneous Glargine insulin (made by Sanofi®) within the first 2 hours of ICU admission. The dose of insulin glargine will be adjusted according to the calculated (eGFR > 90 dose = 0.27 IU/kg/day, eGFR 60-89 dose = 0.25 IU/kg/day, eGFR <60 dose = 0.19 IU/kg/day.
Intervention Type
Other
Intervention Name(s)
normal saline
Intervention Description
regular low dose insulin infusion 0.1 IU/Kg/hour and subcutaneous saline instead of insulin glargine will be given in the control group.
Primary Outcome Measure Information:
Title
Mean time to reversal of diabetic ketoacidosis
Description
Resolution of DKA is defined as blood sugar <200mg/dl plus any two of serum bicarbonate ≥15,pH>7.3, and anion gap less than or equal to 12
Time Frame
48 hours
Title
Total crystalline insulin consumption
Description
Total number of units of insulin infusion consumed for diabetic ketocidosis to resolve
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patients. Type I and type II diabetes mellitus. Patients on insulin and/or oral hypoglycemic therapy. Duration of diabetes more than 5 years. Medical and surgical patients. Exclusion Criteria: Severe persistent hypotension (SBP <80 inspite of receiving 1000ml of normal saline). Acute myocardial infarction. Progressive renal failure or end stage renal disease defined as eGFR < 15ml/min. Liver cell failure. Pregnancy. Need for emergency surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eeman A Bayoumi, MD
Phone
0021001635744
Email
eeman_aboubakr@med.asu.edu.eg
Facility Information:
Facility Name
Ain Shams University
City
Cairo
ZIP/Postal Code
11566
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wael A ElSwefi, MD
Phone
00201114811883
Email
waelelswefi@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23395363
Citation
Barski L, Kezerle L, Zeller L, Zektser M, Jotkowitz A. New approaches to the use of insulin in patients with diabetic ketoacidosis. Eur J Intern Med. 2013 Apr;24(3):213-6. doi: 10.1016/j.ejim.2013.01.014. Epub 2013 Feb 8.
Results Reference
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PubMed Identifier
28864157
Citation
Barski L, Brandstaetter E, Sagy I, Jotkowitz A. Basal insulin for the management of diabetic ketoacidosis. Eur J Intern Med. 2018 Jan;47:14-16. doi: 10.1016/j.ejim.2017.08.025. Epub 2017 Aug 31.
Results Reference
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PubMed Identifier
25018975
Citation
Chapter 1: Definition and classification of CKD. Kidney Int Suppl (2011). 2013 Jan;3(1):19-62. doi: 10.1038/kisup.2012.64. No abstract available.
Results Reference
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PubMed Identifier
21255074
Citation
Savage MW, Dhatariya KK, Kilvert A, Rayman G, Rees JA, Courtney CH, Hilton L, Dyer PH, Hamersley MS; Joint British Diabetes Societies. Joint British Diabetes Societies guideline for the management of diabetic ketoacidosis. Diabet Med. 2011 May;28(5):508-15. doi: 10.1111/j.1464-5491.2011.03246.x.
Results Reference
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PubMed Identifier
11895456
Citation
Svensson M, Yu ZW, Eriksson JW. A small reduction in glomerular filtration is accompanied by insulin resistance in type I diabetes patients with diabetic nephrophathy. Eur J Clin Invest. 2002 Feb;32(2):100-9. doi: 10.1046/j.1365-2362.2002.00949.x.
Results Reference
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Outcome of Glargine Insulin in Renal Impairment Patients With Diabetic Ketoacidosis

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